Regulatory Affairs

Increasingly complex regulatory requirements and rapidly evolving technology can create problems for medical device developers, and we can help you navigate this complexity.

Regulatory

Meeting Regulatory Requirements

Increasingly complex regulatory requirements and rapidly evolving technology can create problems for medical device developers, and we can help you navigate this complexity. Through strategic guidance and input into the product development process the Bannick team’s involvement leads to a more mature regulatory strategy. Let us guide you through the changing regulatory environments.

Bannick Primary is a RAPS medical device regulatory member, and we are here to help you accelerate the device-to-market process anywhere in the world. We know that the most efficient way to get your product to market matters and we will work with you to determine what solution is best suited to your needs.

Our integrated approach helps our global clients overcome regulatory hurdles, assisting from one regulatory milestone to the next, reducing risk and facilitating compliance on the way towards a successful submission.

We want to help you put devices on the market that are safe and effective for patients where the ultimate goal is to improve lives. As an industry leader who has worked in the medical device clinical area, our high-performing, adaptive team is ready for any task.

To learn how Bannick Primary can help you develop a complete regulatory strategy, contact us today.

Our Regulatory Services Include:

Development and execution of regulatory strategies to meet your business objectives

Perform MDD to MDR Gap Assessments and Remediation

Provide support from "napkin" sketch to post market activities

Submission preparation for US, EU and global markets: Tech Docs, PMAs, 510(k)s, DeNovo, IDE applications

Regulatory Compliance

FDA Meeting Planning and Support

Regulatory Affairs
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